Catalogue of hazards: a fundamental part for the safe design of surgical robots

Abstract

Risk classes defined by MDR and FDA for state-of-the-art surgical robots based on their intended use are not suitable as indicators for their hazard potential. While there is a lack of safety regulation for an increasing degree of automation as well as the degree of invasiveness into the patient’s body, adverse events have increased in the last decade. Thus, an outright identification of hazards as part of the risk analysis over the complete development process and life cycle of a surgical robot is crucial, especially when introducing new technologies. For this reason, we present a comprehensive approach for hazard identification in early phases of development. With this multi-perspective approach, the number of hazards identified can be increased. Furthermore, a generic catalogue of hazards for surgical robots has been established by categorising the results. The catalogue serves as a data pool for risk analyses and holds the potential to reduce hazards through safety measures already in the design process before becoming risks for the patient.

Keywords

• computer assisted surgery
• risk management
• safety
• surgical robots
• systematics